Sihuan Pharmaceutical Announces Clinical Research of Favipiravir, Co-Developed with the Academy of Military Medical Sciences of the People's Liberation Army, Has Commenced

HONG KONG, March 2, 2020 /PRNewswire/ -- Sihuan Pharmaceutical Holdings Group Ltd. (HKEX: 0460, "Sihuan Pharmaceutical" or the "Company", together with its subsidiaries, the "Group") is pleased to announce that the clinical research of Favipiravir tablet, which was co-developed by the Group and the Institute of Microbiology Epidemiology of the Academy of Military Medical Sciences of the People's Liberation Army of the People's Republic of China (the "PRC"), has recently commenced for coronavirus disease 2019 ("COVID-19") (the "Trials"). The Trials was officially initiated by the Ministry of Science and Technology in early February. The Human Genetic Resources Management Office of the PRC urgently reviewed the Trials and the Group obtained the human genetic resources administrative license in only one working day (2020GH0006YJ). The Trials is currently underway.

The Trials are led by Beijing Chaoyang Hospital affiliated with Capital Medical University, with Professor Tong Zhaohui as the leading researcher. Another two research centers include Union Hospital affiliated with Tongji Medical College of Huazhong University of Science and Technology and Wuhan Jinyintan Hospital. The Trials are random, parallel dose exploration studies with three dosage groups (high, middle and low dosage) to explore the best treatment regimen of Favipiravir for COVID-19 patients. A total of 60 cases of regular COVID-19 patients are planned to be recruited for a treatment period of 10 days. The Group will explore to identify more reasonable and effective clinical treatment regimen through clinical research, and will initiate efficacy and safety verification trials of larger scale once expected results are obtained from the Trials.

Favipiravir is a broad-spectrum ribonucleic acid ("RNA") polymerase inhibitor. After oral absorption, it is converted into a bioactive nucleoside triphosphate compound, which is similar in structure to purine, and thus can compete with purine to inhibit RNA polymerase, thereby inhibiting virus replication. In addition, it is found that the nucleoside triphosphate compound of Favipiravir can also be inserted into the virus RNA chain, inducing fatal mutation of the virus. The mechanism of Favipiravir has potential antiviral effects on various RNA viruses. On 15 February 2020, the Defense and Control Joint Constitution of the State Council held a press conference and specifically mentioned three drugs which included Favipiravir, from 70,000 core drug compounds through mock screening and multiple rounds of in-vitro experiments. The press conference also introduced several focused drugs after three rounds of research and development screening, which will conduct clinical trials thereafter.

The Group received the "Army Special Needs Drug Approval" for Favipiravir as an anti-Ebola virus drug in 2014. The effectiveness and safety towards the anti-Ebola virus treatment has been proved by the supporting data and Favipiravir is used for emergency treatment in the event of Ebola virus's outbreak in Africa.

Dr. Che Fengsheng, Chairman and Executive Director of Sihuan Pharmaceutical said, "After all the efforts and preparations, our Group is fully prepared for Favipiravir's raw material and preparation production. Once approved, Favipiravir tablets will be provided for free as a treatment protection for COVID-19 patients during the epidemic, bringing good news to patients. Sihuan Pharmaceutical will contribute to overcome the epidemic with social responsibility and strength."

About Sihuan Pharmaceutical Holdings Group Ltd.

Founded in 2001, Sihuan Pharmaceutical is a pharmaceutical group with 21 subsidiaries and integrated R&D, production and marketing and sales capabilities. Because of the continuing efforts over the past decade, Sihuan Pharmaceutical has formed a R&D platform with over 1,000 researchers conducting more than 110 pharmaceutical research projects currently. More than 300 patents on innovative drugs were granted in China and over 80 are PCT patents, covering pipeline projects including important areas of diabetes, oncology, anti-infectives and non-alcoholic steatohepatitis etc.